Senior QM R&D Engineer - Risk Management Lead (Global)

Ambu A/S; Ballerup Kommune; Hybrid; DKK 522,388 - 671,642; Full time

Benefits offered by this job

Opportunities for personal and professional development

Dynamic and diverse work environment

Wide range of employee benefits

Job summary

Ambu A/S is seeking a Senior Quality Management R&D Engineer in Ballerup, Denmark. This role focuses on driving risk management and quality assurance for medical device development, requiring a strong foundation in quality and compliance.

The ideal candidate should have a BSc/MSc with over 3 years in a regulated industry, excellent communication skills, and experience in quality engineering. Join a dynamic team at a leading medical device company dedicated to innovation and collaboration.

Qualifications

• 3+ years of experience in a regulated industry (medical devices or pharma).
• In-depth knowledge of quality standards applicable to medical devices.
• Experience in R&D projects of medical devices.

Responsibilities

• Drive Risk Management for both new and existing products.
• Serve as the Quality Management partner for global R&D projects.
• Carry out Life Cycle Management activities.
• Support non-conformities and CAPA activities.

Skills

Risk Management

Quality Engineering

ISO 14971

ISO 13485

EU MDR

Communication Skills

Education

BSc/MSc in a relevant field

Job description

Ambu A/S is seeking a Senior Quality Management R&D Engineer in Ballerup, Denmark. This role focuses on driving risk management and quality assurance for medical device development, requiring a strong foundation in quality and compliance.

The ideal candidate should have a BSc/MSc with over 3 years in a regulated industry, excellent communication skills, and experience in quality engineering. Join a dynamic team at a leading medical device company dedicated to innovation and collaboration.